Briefing back to top
and pharmaceuticals: fact sheet
A basic explanation, with extracts of the legal
text. You can browse
the fact sheet or download in Word format or in
and print it.
Frequently asked questions: compulsory licensing of pharmaceuticals
patents and the TRIPS Agreement
A more technical explanation.
Paragraph 6 System back to top
‘Paragraph 6’ — importing under compulsory licensing — explained: Press releases 2003 on waiver, 2005 on amendment; in fact sheet; and in detail in extract from 2013 WHO-WIPO-WTO study (pdf)
Annual reports on ‘Paragraph 6’ implementation
How to accept the
protocol amending the TRIPS Agreement:
Background information for members on procedures
implementation legislation: the countries that have changed
their laws to implement the “Paragraph 6 System”.
Illustrative guide to notifying under the Paragraph 6 System
Official texts back to top
The WTO Members have adopted the following instruments on TRIPS and public health:
17 of the main Doha Declaration, adopted on 14 November 2001 by the Fourth WTO Ministerial
Conference, Doha, Qatar.
Declaration on the TRIPS Agreement and Public Health, adopted on
14 November 2001 by the Fourth WTO Ministerial
Conference, Doha, Qatar.
Decision on the Extension of the Transition Period under Article 66.1
of the TRIPS Agreement for Least-Developed Country Members for Certain
Obligations with Respect to Pharmaceutical Products, adopted by the
TRIPS Council on 27 June 2002. This Decision implements the second
and third sentences of paragraph 7 of the Doha Declaration on the
TRIPS Agreement and Public Health. Least-developed countries
will not have to protect pharmaceutical patents and test data until
1 January 2016.
Decision on Least-Developed Country Members — Obligations Under
Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical
Products, adopted by the General Council on 8 July 2002. This Decision
was also taken with a view to ensuring attainment of the objectives of
paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public
Health. It says least-developed countries will not have to give
exclusive marketing rights to pharmaceuticals that are subject of a
patent application until 1 January 2016.
Decision on the Implementation of Paragraph 6 of the Doha Declaration
on the TRIPS Agreement and Public Health, adopted by the General
Council on 30 August 2003. This “waiver” removes limitations
on exports under compulsory licence to countries that cannot
manufacture the pharmaceuticals themselves. This Decision was adopted by the General
Council in the light of a statement read out by the Chairman.
Decision on the Amendment of the TRIPS Agreement,
adopted by the General Council, 6 December 2005. The decision adopts a
Protocol of Amendment that is open for members to accept. The
amendment itself will come into force after two thirds of members have
accepted it, and will replace the August 2003 decision, as instructed
in Paragraph 11 of that text. The decision was adopted in the light of
a statement read out by the chairperson, who also read out a
statement on “non-violation” complaints.
> How many members have accepted the amendment?
- 2005: Hong Kong Ministerial Declaration
Paragraph 40 on TRIPS and Public Health
- 2007: Decision to extend deadline for accepting TRIPS Agreement amendment
- 2009: Decision to extend deadline for accepting TRIPS Agreement amendment
- 2011: Decision to extend deadline for accepting TRIPS Agreement amendment